献血者未鉴别反应性标本的HBV检测优化OA
Optimization of HBV detection in NDR samples from blood donors:cross-validation based on repetitive testing and NAT systems with different principles
目的 探讨采用不同原理核酸检测(NAT)系统重复检测并交叉验证的检测策略,以提高未鉴别反应性(NDR)标本中隐匿性 HBV 感染(OBI)的检出率.方法 选取太原市血液中心 2024 年 8 月—2025 年 5 月的 89 份NDR 标本作为研究对象.所有标本均经 HBsAg ELISA 检测和罗氏系统(PCR 法)NAT;对所有 HBsAg-,MP-NAT+/ID-NAT-(NDR)的标本,进一步采用罗氏系统重复 ID-NAT 及基立福系统(TMA 法)dHBV 重复鉴别试验进行交叉验证,同时检测 HBV 血清学标志物,并经荧光定量 PCR 及巢式 PCR 测序分型确认.采用 NAT 单阳性率-窗口期比率模型评估罗氏单一系统实际应用的 HBV 输血残余风险,同时以理论推算方式评估假设基立福系统用于全体献血者单人份筛查时的残余风险水平.结果 NDR 标本检出率为 0.99‰(89/90 115),与全国平均水平一致.89 份 NDR标本中,4 份经巢式 PCR 确认为 HBV DNA+(病毒载量 15-20 IU/mL),其中 3 份基因型为 C1、1 份基因型为 B2.血清学标志物分析显示:NDR 标本中抗-HBc 阳性率达24.7%(22/89),4 份OBI 标本均为抗-HBc+标本(18.2%),且均未检出抗-HBs.单一 NAT 系统中,罗氏系统与基立福系统的初次献血者残余风险(RRFD)分别为 48.98/106 py 和21.01/106 py,均高于其重复献血者残余风险(RRRD)15.23/106 py 和 9.80/106 py,但差异无统计学意义(P>0.05).结论 实施重复检测联合不同原理 NAT 系统交叉验证,可有效提高低病毒载量 OBI 的检出率,减少漏检风险.
Objective To evaluate the effect of repeated testing combined with cross-validation using different princi-ples of NAT systems on improving the detection rate of occult HBV infection(OBI)in HBsAg-negative/NDR samples.Methods A total of 89 NDR samples from the Taiyuan Blood Center between August 2024 and May 2025 were enrolled.All samples were tested for HBsAg by ELISA and subjected to NAT screening using the Roche system(PCR method).For all HBsAgnegative,MPNAT+/IDNAT(NDR)samples,further crossvalidation was performed using repeat IDNAT with the Roche system and the Grifols system(TMAbased)dHBV discriminatory assay;in addition,HBV serological markers were detected,and the results were confirmed by realtime quantitative PCR and nested PCR with sequencing genotyping.The NAT yield/window period ratio model was used to estimate the residual risk of HBV transfusion for the Roche single system in actual use,and the theoretical residual risk was calculated by assuming that the Grifols system was applied to individual screening of all blood donors.Results The detection rate of HBsAg-negative/NDR was 0.99‰(89/90 115),consistent with the national average.Among the 89 NDR samples,4 were confirmed as HBV DNA-positive by nested PCR(viral load 15 – 20 IU/mL),including 3 of genotype C1 and 1 of genotype B2.Serological analysis showed that the anti-HBc positivi-ty rate in NDR samples was 24.7%(22/89);all 4 OBI samples were antiHBcpositive(18.2%)and none were antiHB-spositive.In the single-NAT system,the residual risk for first-time donors(RR_FD)was 48.98/106 person-years for the Roche system and 21.01/106 person-years for the Grifols system,both higher than the corresponding residual risk for repeat donors(RR_RD:15.23/106 and 9.80/106 person-years,respectively),but the differences showed no statistical signifi-cance(P>0.05).Conclusion Implementing repeated testing combined with cross-validation using different principles of NAT systems can effectively increase the detection rate of low-viral-load OBI and reduce the risk of missed detection.
张强;周源;张柳明;原维宇;陕柏峰;李之烨;窦丽霞;褚爱春;贺雪花
太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024太原市血液中心 太原市输血技术研究所,山西 太原 030024山西白求恩医院,山西 太原 030032
医药卫生
输血安全隐匿性乙型肝炎未鉴别反应性双重检测策略残余风险分析
blood safetyoccult hepatitis Bnon-discriminated reactivedual detection strategyresidual risk analysis
《中国输血杂志》 2026 (9)
1223-1230,8
太原市"六个一批"专项行动(Z2024007)
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